QA Engineering Supervisor

Position Summary

In this exciting role as a Quality Engineer Supervisor you will have responsibility for leading teams through Quality System Transformation by defining and trending metrics. This role will lead multiple projects within a larger program with a focus on creating more usable and simpler to follow processes, reducing burden within our quality systems and driving efficiency.

Responsibilities

• Work collaboratively with cross functional teams to track data, identify improvement projects and implementation to drive improvements to Key Performance Indicators.
• Schedule and participate in activities to support and maintain compliance with applicable regulatory and Quality Management System requirements.
• Support the maintenance and development of the Corrective And Preventative Action (CAPA) and internal Non-Conformance system to support the overall facility quality management system.
• People supervision and process management of elements under your responsibility.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Ensure products adhere to company and industry quality standards
• Drive proactive Quality improvements in partnership with all related business functions.
• Formulate strategic plans to increase productivity in the business
• Works within an operations team to identify and implement effective controls to support the development, qualification, and distribution of products to meet or exceed internal and external requirements
• Partners with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant Quality System.
• Perform statistical analysis to determine process capability and to analyze trends
• Maintains schedules for projects; identifies problems and recommends solutions to all project activities.
• Generate, analyze, and present reports on quality related Key Performance Indicators (KPI) such as ship holds, service errors, line yields, final release, supplier performance and customer experiences to internal product improvement teams
• Acts as an effective leader and team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
• Support audits, CAPA/NC/MRB investigations and reports
• Management of quality process within the facility and supervision of personnel
• Previous experience overseeing a team, quality supervisor experience is preferred
• People management skills, conflict resolution and results oriented.
• Perform other related duties as assigned

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s Degree with 5+ years of work experience in Quality and/or experience in a regulated industry OR Advanced Degree with 3+ years of work experience in Quality and/or experience in a regulated industry.
• Knowledge of Quality Systems Requirements (ISO 13485, CFR 820 & LATAM)
• Knowledgeable of Board of Pharmacy and NABP requirements
• Experience and knowledge working with product holds, nonconforming products, and recalls
• Experience and knowledge working with NC’s (nonconformances) and CAPA’s
• Internal / External QMS Audit experience
• Green Belt / Black Belt Certificate (or experience) preferred
• Process Development Experience
• Project Management Experience
• Quality Agreements
• Schedule management
• Experience with SAP/Blue, Younder, and eQMS systems, like Veeva Vault, Agile, Mastercontrol applications (desirable)
• Ability to become NABP Designated Representative

• Adept at relationship building across functions and geography to effectively work with and leverage centers of excellence.
• Excellent computer skills (MS Word, Excel, and PowerPoint)
• Detail oriented and strong data driven analytical approach to HR processes
• Effective with combining Business and HR Acumen to build organizational capability
• Able to support employees on multiple shifts; ability to be flexible with…